Investigation of Specific Protein/Markers in Patients With Osteoarthritis of the Knee Having a Total Knee Replacement
Osteoarthritis of the Knee
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Investigation of Biomarkers in an Exploratory Study in Patients With Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery|
- Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee. [ Time Frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery) . ]
- Biomarkers in synovial fluid, synovial membrane, and cartilage. [ Time Frame: Day 1 (surgery). ]
- Biomarkers in blood and urine. [ Time Frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery). ]
- Biomarkers by Magnetic Resonance Imaging (MRI). [ Time Frame: 1-5 days prior to day 1 (surgery). ]
- Polymorphisms in 10 specific genes. [ Time Frame: 3-20 days prior to day 1 (surgery) or at any time in the study. ]
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) variables and NPQ (Neuropathic Pain Questionnaire) variables. [ Time Frame: 3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery). ]
WOMAC consists of 3 subscales with a total of 24 questions regarding pain, stiffness and difficulty in performing daily activities. A VAS (Visual Analogue Scale) will be used for the patient to report the severity of the symptoms on the target knee. Endpoints are marked "No pain" (0 mm) and " Extreme pain" (100 mm) on a paper PRO (Patient Reported Outcome) questionnaire. The less pain scored the better outcome.
NPQ accesses 12 different pain intensities. 0 represents no intensity and 100 represents worst intensity imaginable. The less intensity the better outcome.
Biospecimen Retention: Samples With DNA
|Study Start Date:||December 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Patients with osteoarthritis of the knee
Patients with osteoarthritis of the knee undergoing total knee replacement surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611441
|Study Director:||Rolf Karlsten, MD, PHD||AstraZeneca R&D Sodertalje, Sweden|